Negram - Pharmacology:

Negram for patients

Patients should be advised NegGram may be taken with or without meals. Patients should be advised to drink fluids liberally and not take antacids.

Patients should be advised that quinolones may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reactions.

Quinolones may cause dizziness and lightheadedness, therefore, patients should know how they react to NegGram before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.

Patients should be advised that quinolones may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones. Patients should be advised to avoid excessive sunlight or artificial ultraviolet light while receiving nalidixic acid and to discontinue therapy if phototoxicity occurs.

Patients should be advised that convulsions have been reported in patients taking quinolones, including Nalidixic acid, and to notify their physician before taking this drug if there is a history of this condition. Patients should be advised that mineral supplements, vitamins with iron or minerals, calcium-, aluminum-, magnesium-based antacids, sucralfate or Videx®, (Didanosine), chewable/buffered tablets of the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking nalidixic aid.

Negram Interactions

Elevated plasma levels of theophylline have been reported with concomitant quinolone use. There have been reports
of theophylline-related side effects in patients on concomitant therapy with quinolones and theophylline. Therefore,
monitoring of theophylline plasma levels should be considered and dosage of theophylline adjusted, as required.

Quinolones have been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of
caffeine and the prolongation of its plasma half-life.

Quinolones, including nalidixic acid, may enhance the effects of the oral anticoagulant warfarin or its
derivatives. When these products are administered concomitantly, prothrombin time or other suitable coagulation test
should be closely monitored.

Nitrofurantoin interferes with the therapeutic action of nalidixic acid.

Antacids containing magnesium, aluminum, or calcium; sucralfate or divalent or trivalent cations such as iron;
multivitamins containing zinc; and Videx®, (Didanosine), chewable/buffered tablets or the pediatric powder for
oral solution may substantially interfere with the absorption of quinolones, resulting in systemic levels
considerably lower than desired. These agents should not be taken within the two hour period before or within the
two-hour period after nalidixic acid administration.

Elevated serum levels of cyclosporine have been reported with the concomitant use of some quinolones and
cyclosporine. Therefore, cyclosporine serum levels should be monitored and appropriate cyclosporine dosage
adjustments made when these drugs are used concomitantly.

Negram Contraindications

NegGram is contraindicated in patients with known hypersensitivity to nalidixic acid and in patients with a
history of convulsive disorders.